- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07388745
ESPB vs SPSIP for Postoperative Analgesia After CABG (ESP-SPSIP-CABG)
May 10, 2026 updated by: Merve Yaman, Kutahya Health Sciences University
A Randomized Trial Comparing Erector Spinae Plane Block Versus Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesic Efficacy in Patients Undergoing Coronary Artery Bypass Graft Surgery
This prospective, randomized, active-controlled, double-blind, parallel-group study compares the postoperative analgesic efficacy and safety of ultrasound-guided bilateral Erector Spinae Plane Block (ESPB) versus bilateral Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in adult patients (45-85 years, ASA I-III) undergoing elective coronary artery bypass graft surgery.
The primary outcome is postoperative pain intensity assessed by Numeric Rating Scale (NRS) at 2, 4, 8, 16, 24, and 48 hours after surgery.
Secondary outcomes include intraoperative fentanyl/remifentanil consumption, postoperative morphine consumption, patient-controlled analgesia (PCA) demand/delivery parameters (if PCA is used), need for rescue analgesics, extubation and mobilization times, peak inspiratory flow measured by incentive spirometry at predefined time points, ICU and hospital length of stay, recovery quality (QoR-15 at 0, 24, and 48 hours), mortality, and block-related adverse events.
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Merve Yaman, Assistant Professor
- Phone Number: +905363794742
- Email: merve.yaman@ksbu.edu.tr
Study Locations
-
-
Kütahya
-
Kütahya, Kütahya, Turkey (Türkiye), 43100
- Recruiting
- Kütahya Health Sciences University Hospital
-
Contact:
- Merve Yaman
- Phone Number: 05363794742
- Email: drmerveyaman@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 45-85 years
- Scheduled for elective coronary artery bypass graft (CABG) surgery
- American Society of Anesthesiologists (ASA) I-II-III
- Patients who provide written informed consent and agree to participate in the study
Exclusion Criteria:
- Emergency cases
- ASA IV-V
- Known allergy to local anesthetics
- Coagulopathy (platelet count <100,000/mm³, INR >1.5, aPTT >1.5× normal)
- Infection at the block injection site
- Pregnancy
- Patients who do not provide written informed consent or decline to participate after being informed
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Erector Spinae Plane Block (ESPB)
Ultrasound-guided bilateral Erector Spinae Plane Block will be performed preoperatively under sedation at the T4-T5 transverse process level.
A total of 20 mL of 0.25% bupivacaine will be injected per side (total 40 mL).
All participants will receive standardized general anesthesia for CABG and the same postoperative multimodal analgesia protocol.
|
Bilateral ultrasound-guided ESPB performed preoperatively under sedation at the T4-T5 transverse process level using 20 mL of 0.25% bupivacaine per side (total 40 mL).
|
|
Experimental: Serratus Posterior Superior Intercostal Plane Block (SPSIPB)
Ultrasound-guided bilateral Serratus Posterior Superior Intercostal Plane Block will be performed preoperatively under sedation at the 2nd-3rd intercostal space.
A total of 20 mL of 0.25% bupivacaine will be injected per side (total 40 mL).
All participants will receive standardized general anesthesia for CABG and the same postoperative multimodal analgesia protocol.
|
Bilateral ultrasound-guided SPSIPB performed preoperatively under sedation at the 2nd-3rd intercostal space using 20 mL of 0.25% bupivacaine per side (total 40 mL).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity
Time Frame: 2, 4, 8, 16, 24, and 48 hours after surgery
|
Pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 = no pain and 10 = worst imaginable pain.
Higher scores indicate worse pain.
|
2, 4, 8, 16, 24, and 48 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative postoperative opioid consumption
Time Frame: First 24 hours after surgery
|
Total opioid dose for analgesia converted to IV morphine equivalents.
|
First 24 hours after surgery
|
|
Need for rescue analgesia
Time Frame: Up to 48 hours after surgery
|
Proportion of participants requiring rescue analgesics in addition to the standardized protocol.
|
Up to 48 hours after surgery
|
|
Quality of Recovery (QoR-15) score
Time Frame: Baseline (preoperative), postoperative 24 hours, and 48 hours after surgery
|
"The Quality of Recovery-15 questionnaire (QoR-15) is a patient-reported measure consisting of 15 items.
Each item is scored from 0 (unfavourable) to 10 (favourable), resulting in a total score ranging from 0 to 150.
Higher total scores indicate better postoperative recovery.
|
Baseline (preoperative), postoperative 24 hours, and 48 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Merve Yaman, Assistant Professor, Kütahya Health Sciences University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
January 25, 2026
First Submitted That Met QC Criteria
February 4, 2026
First Posted (Actual)
February 5, 2026
Study Record Updates
Last Update Posted (Actual)
May 13, 2026
Last Update Submitted That Met QC Criteria
May 10, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSBÜ-KVC-CABG-ESPB-SPSIPB-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain Management
-
Elazıg Fethi Sekin Sehir HastanesiNot yet recruiting
-
Zagazig UniversityCompletedPostoperative Pain ManagementEgypt
-
University of California, Los AngelesNot yet recruitingPostoperative Pain Management
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedPostoperative Pain ManagementTurkey (Türkiye)
-
Aydin Adnan Menderes UniversityCompleted
-
Zagazig UniversityNot yet recruitingPostoperative Pain Management | Postoperative Analgesia
-
Rhode Island HospitalRecruitingPostoperative Pain ManagementUnited States
-
Haisco Pharmaceutical Group Co., Ltd.RecruitingPostoperative Pain ManagementChina
-
Shenyang Sixth People's HospitalWithdrawnPostoperative Pain ManagementChina
-
Haisco Pharmaceutical Group Co., Ltd.CompletedPostoperative Pain ManagementChina
Clinical Trials on Ultrasound-guided Erector Spinae Plane Block (ESPB)
-
Alexandria UniversityCompletedPain Management | PCNL | Postoperative Analgesia | Regional Anesthesia BlockEgypt
-
Mater Misericordiae University HospitalUnknown
-
Alexandria UniversityCompletedChildren | Erector Spinae Plane Block | Caudal Block | Caudal Block for Postoperative Analgesia | Caudal Anesthesia | Local Analgesia Via Infiltration | Caudal Epidural AnesthesiaEgypt
-
Istanbul Saglik Bilimleri UniversityCompletedColorectal Surgery | Robotic Surgery | Erector Spinae Plane Block | Postoperative Pain ManagementTurkey (Türkiye)
-
TC Erciyes UniversityCompletedBreast Cancer | Postoperative PainTurkey
-
Assiut UniversityCompletedPain, Postoperative | Pulmonary Atelectasis | MastectomyEgypt
-
Karabuk UniversityCompletedPain Management | Erector Spina Plan Block | External Oblique Intercostal BlockTurkey (Türkiye)
-
Qianfoshan HospitalNot yet recruitingErector Spinae Plane Block | Neutrophil to Lymphocyte Ratio
-
Tanta UniversityNot yet recruitingPain, Acute | Pain, Chronic | Erector Spinae Plane Block | Thoracic Interfascial Plane Block | Mastectomy, Modified Radical
-
Sohag UniversityNot yet recruitingLaparoscopic Cholecystectomy Surgery Postoperative AnalgesiaEgypt